Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of orally administered ds102 in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this randomised, double-blind, placebo-controlled, parallel group study is to assess the safety and efficacy of orally administered ds102 capsules versus placebo in the treatment of adult patients with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * patients (male or female) aged 40-75 years with stable copd at the time of screening. * patients who are current or ex-smokers who have a smoking history of at least 10 pack years (ten pack- years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years). * patients whose pre-study clinical laboratory findings do not interfere with their participation in the study, in the opinion of the investigator. * patients who are able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent. exclusion criteria: * patients with a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. * patients with significant systemic or major illness other than pulmonary disease, including coronary artery disease, liver disease, cerebrovascular disease, renal insufficiency, serious psychiatric disease, respiratory or hypertensive disease, as well as diabetes and arthritis that, in the opinion of the investigator, would preclude the patient from participating in and completing the study. * patients with known hypersensitivity to any ingredients of the study treatment. * patients, in the opinion of the investigator, not suitable to participate in the study
artificial intelligence-based prescription of personalized scalp cosmetics

Conditions: Dandruff; Folliculitis

Summary: the investigators aimed to evaluate whether they can be improved by an ai-based personalized prescription of scalp cosmetics.


Eligibility criteria:
inclusion criteria: 1. healthy adults aged \>19 years 2. presence of scalp-related discomfort (such as itching, a sensation of heat, dandruff, excessive sebum, dryness, pain, or pimple) exclusion criteria: 1. presence of active infectious scalp diseases 2. history of treatment with topical or systemic steroids, oral immunosuppressants, topical or systemic antibiotics, or antifungal agents that could affect the scalp conditions, within 4 weeks prior to the baseline 3. difficulty understanding or following the protocol
assessment of pharyngeal carriage of microorganisms responsible for transmissible acute respiratory infections in hajj pilgrims.

Conditions: Acute Respiratory Infection

Summary: the objective of this project is to study the prevalence of viruses and bacteria responsible for transmissible acute respiratory infections in the respiratory tract of pilgrims returning from the trip. the patients included, will be the consultant pilgrims to the traveler health center, and before leaving for hajj. based on the results obtained in previous studies, it is estimated that 200 pilgrims will be included each year, 600 in total (inclusion period of 3 years). respiratory secretions are then collected by nasal swab and throat (swab) prior to departure for the hajj. in return, patients will be reconvened systematic consultation to record medical events potentially encountered during the trip, and it will again be performed the same nasal swabs and throat. it will then be performed on these samples' return from hajj "molecular detection (pcr and rt-pcr) of 35 viruses and bacteria respiratory tropism: influenza (3), rsv (2), metapneumovirus (1), coronavirus (4), parainfluenzavirus (4), enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus, polyomavirus (2), pneumococcus, bordetella pertussis, mycoplasma pneumoniae, chlamydophila pneumoniae, haemophilus influenzae, neisseria meningitidis and coxiella burnetii. samples "return of hajj" positive should be cultured for the isolation of the strain. for patients positive return, it will be done further research of these 35 viruses and bacteria on samples "start of hajj," the same method described above. in addition to this systematic consultation, and if symptoms return, the pilgrims will be seen in consultation for a diagnosis evaluation and therapeutic management. this study will shed light on the acquisition of microorganisms respiratory tropism during the stay and on the potential risks associated with the circulation of these pathogens after the trip.


Eligibility criteria:
inclusion criteria: * all travelers presenting during the study period in the service of international vaccination for mandatory meningococcal acyw135 vaccination , * affiliated to a social security insurance regime * male or female * aged over 18 years * having signed informed consent form * able to understand and answer the study questions exclusion criteria * patients aged under 18 * patient whose protocol compliance seems unlikely to investigator * participant in another clinical trial or in exclusion period of a previous clinical trial, * unable to understand the nature and objectives of the study, * refusing to sign the informed consent form.

Keywords: microorganisms pilgrim hajj
vitamin d sulfates in breastmilk

Conditions: Vitamin D Deficiency; Breast Milk Collection

Summary: infants the purpose of this study is to measure breastmilk's vitamin d sulfate nutritional value in infant's saliva and digesta (gut). breastfeeding mothers the purpose of this study is to measure vitamin d sulfates in freshly expressed breastmilk samples before and after 28 days of vitamin d supplementation in lactating mothers.

infants sign the consent form to confirm participation: you will be asked to bring a soiled diaper from the morning of the study visit. you will meet with a study team member who will collect up to 6 swabs total: up to 3 cheek/mouth swabs to collect saliva up to 3 stool/anus/diaper swabs lactating mothers sign the consent form to confirm participation: visit 1 (baseline) you will meet with a study team member complete some demographic information and gestational age of the baby and birthdate, next you will have a blood draw and express breast milk in a private location, the study team will collect up to 50 ml of freshly expressed breast milk for the research study, you will be asked to bring your personal breast pump and collection container to each research visit, or manually express milk, see options below. the study team member will schedule visit 2. the study will provide the vitamin d supplement that you will take daily for 28 days. visit 2 (post intervention) approximately 28 days later you will meet with a study team member, have a blood draw and express breast milk in a private location, the study team will collect up to 50 ml of freshly expressed breast milk for the research study, you will be asked to bring your personal breast pump and collection container to each research visit, or manually express milk, see options below. the study team member will ask for the container the vitamin d supplement was in. you have 2 options: option 1: bring along your personal breast pump and collection container to each study visit. the study team member will collect up to 50 ml of freshly expressed breast milk for the study. option 2: you do not bring along your personal breast pump and containers to each study visit, instead you will be asked to: manually express your breast milk into a specimen collection cup at each study visit.

Eligibility criteria:
lactating mothers inclusion criteria: * lactating mothers * ≥2 weeks after delivery * no intentions of weaning during the study exclusion criteria: * history of sarcoidosis * history of renal disease * premature birth- \<37 weeks * taking daily supplement with ≥600 iu vitamin d in the past 30 days breastfeeding infants inclusion criteria: * female and male infants * exclusively breastfed exclusion criteria: * no known gastrointestinal diseases that require medical treatment * currently prescribed antibiotics or have taken antibiotics \<2 weeks from collection
mucinb5 gene polymorphism and leucocytes telomere length in interstitial lung diseases

Conditions: Mucin B5 rs (35705950) Gene Polymorphism in Interstitial Lung Diseases

Summary: this is an observertional study aimed at study the association between mucin b5 rs (35705950) gene polymorphism and leucocytes telomere length in relation to interstitial lung diseases.


Eligibility criteria:
inclusion criteria: this study will include patients with interstitial lung diseases aged above 18 years old. exclusion criteria: * patients with emphysema or obstructive lung diseases. * patients with active cancer * end stage renal failure (gfr \< 30 ml/min) or on dialysis * liver cell failure
effects of corrective exercises and postural education on forward head posture

Conditions: Musculoskeletal Deformity

Summary: forward head posture is one of the most common postural problems that we face today. sitting for long periods in poor posture and the excessive use of electronic devices has become a high risk for this postural abnormality. the goal of this \[interventional study\] is to \[provide the participants with simple and easy corrective exercises for this abnormal posture which they can do anywhere at any time and to provide postural education and awareness on the matter.

forward head posture is one of the most common postural problems that we face today. sitting for long periods in poor posture and the excessive use of electronic devices has become a high risk for this postural abnormality. the goal of this \[interventional study\] is to \[provide the participants with simple and easy corrective exercises for this abnormal posture which they can do anywhere at any time and to provide postural education and awareness on the matter. also, this study aims in comparing both the treatment and education.\] in \[the people who have forward head posture or are more likely to develop it\]. the main question\[s\] it aims to answer are: * does corrective exercises have any effect on improving forward head posture? * does postural education has any effect on improving forward head posture? participants in \[-exercise group will perform corrective exercises for 6 weeks * postural education group will follow postural guidelines while doing daily tasks for 6 weeks * control group will do nothing in 6 weeks\]. researchers will compare \[corrective exercise group with postural education group and control group\] to see if \[corrective exercise group or postural education group has any effect on forward head posture and compare the results with the control group\].

Eligibility criteria:
inclusion criteria: 1. consent to participate in the study. 2. young \& middle-aged adults between the ages of 20-40 years 3. craniovertebral angle less than or equal to 50° 4. shoulder angle less than or equal to 52° exclusion criteria: 1. history of trauma 2. acute neck injuries e.g., whiplash 3. surgical history

Keywords: forward head posture corrective exercises postural education craniovertebral and shoulder angles posture musculoskeletal
healey als platform trial - regimen g dnl343

Conditions: Amyotrophic Lateral Sclerosis

Summary: the healey als platform trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of als. regimen g will evaluate the safety and efficacy of a single study drug, dnl343, in participants with als.

the healey als platform trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of als. this trial is designed as a perpetual platform trial. this means that there is a single master protocol dictating the conduct of the trial. the healey als platform trial master protocol is registered as nct04297683. once a participant enrolls into the master protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. all participants will have an equal chance of being randomized to any currently enrolling regimen. if a participant is randomized to regimen g dnl343, the participant will complete a screening visit to assess additional regimen g eligibility criteria. once regimen g eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active dnl343 or matching placebo. regimen g will enroll by invitation, as participants may not choose to enroll in regimen g. participants must first enroll into the master protocol and be eligible to participate in the master protocol before being able to be randomly assigned to regimen g. for a list of enrolling sites, please see the healey als platform trial master protocol under nct04297683.

Eligibility criteria:
inclusion criteria: * no additional inclusion criteria beyond the inclusion criteria specified in the master protocol (nct nct04297683). exclusion criteria: * the following exclusion criteria are in addition to the exclusion criteria specified in the master protocol (nct nct04297683). 1. diagnosis of epilepsy or seizure within 6 months of randomization 2. hypersensitivity to dnl343 or any of the excipients contained within the dnl343 drug product 3. the concomitant use of prescription or over-the-counter (otc) medications that are inducers of certain cytochrome p450 enzymes, substrates of certain cytochrome p450 enzymes, or substrates of certain drug transporters.

Keywords: als placebo-controlled double-blind regimen specific appendix lou gehrig's disease dnl343 denali therapeutics
a trial comparing the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in japanese subjects with type 2 diabetes mellitus.

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of the trial is to compare the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in japanese subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * male or female japanese subjects at least 20 years of age at the time of informed consent * type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening * hba1c 7.5-10.0% \[58 mmol/mol-86 mmol/mol\] (both inclusive) * subjects on stable therapy with one oad (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved japanese labelling exclusion criteria: * treatment with insulin within 12 weeks prior to screening * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening * screening calcitonin equal or above 50 ng/l * history of pancreatitis (acute or chronic) * personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men 2) * subjects presently classified as being in new york heart association (nyha) class iv * within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack * diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas) * any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
pharmacokinetic and tolerability of alirocumab sar236553 (regn727) in patients with hepatic impairment and in healthy subjects

Conditions: Hypercholesterolemia

Summary: primary objective: study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab sar236553 (regn727). secondary objectives: * assess the safety and tolerability of alirocumab sar236553 (regn727) in patients with mild and moderate hepatic impairment and in matched subjects with normal hepatic function. * assess the pharmacodynamic profile of alirocumab sar236553 (regn727) in patients with hepatic impairment and in matched subjects with normal hepatic function.

total duration of the study per subject (excluding screening) is about 12 weeks.

Eligibility criteria:
inclusion criteria : * male or female, between 18 to 75 years of age, inclusive. * patients with mild and moderate hepatic impairment based on child-pugh score and stable chronic liver disease. * healthy subjects with normal hepatic function. exclusion criteria: * patients with acute hepatitis, hepatic encephalopathy grade 2, 3, and 4. * patients with history or presence of uncontrolled clinically relevant illness. * healthy subjects with history or presence of clinically relevant illness. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effect of a dietary fatty acid supplementation on symptoms and bronchial inflammation in patients with asthma

Conditions: Allergic Asthma; Allergy to House Dust Mite

Summary: the proposed study will investigate the effect of a polyunsaturated fatty acid / lipid mixture (lcpufas) on the clinical symptoms, bronchial inflammation and lung function in allergic asthma in a bronchial allergen provocation (bap) model. for this purpose, patients with stable episodic asthma and dust mite allergy will underwent bap before and after supplementation with lcpufas. the clinical symptoms, bronchial inflammation, exhaled no increase and lung function decline (fev1) will be analyzed.

asthma is a chronic lung disease, which is characterized by recurrent obstruction, a hypersensitivity and a chronic inflammation of the airway. it is known that lcpuvas could reduce the production of inflammatory mediators. in addition, lcpuvas can improve pulmonary function, with a concurrent reduction in bronchodilator use in patients with asthma. subjects suffering from episodic asthma and house dust mite (hdm) allergy usually have a normal lung function testing at rest and show a decrease in lung function when they are exposed to hdm. bronchial allergen provocation models are well established in asthma research and allow the evaluation of anti-allergic and anti-asthmatic agents in relatively small sample sizes. in a previous study the investigators could show, that lcpuvas could reduce exhaled no after repeated bap with hdm. in this study the investigators will investigate the protective effect of lcpuvas in a repeated bap model. clinical symptoms (nasal and bronchial), exhaled no, decrease in lung function the early asthmatic reaction (ear), the late asthmatic reaction (lar) and blood parameters (triglyceride and cholesterin and mircro rnas) will be measured before and after lcpuva supplementation.

Eligibility criteria:
inclusion criteria: * informed consent * patients: aged ≥18 and 45 years * known allergen induced asthma and hdm-allergy * basic lung function fvc ≥ 80%, fev1 ≥ 75% * decrease in fev1 after bap ≥ 20% * 30% increase of no after bap exclusion criteria: * lung function forced vital capacity (fvc) \<80% and forced expiratory volume in 1 second (fev1) \<75% * chronic diseases or infections (e.g. hiv, tbc) * pregnancy * systemic corticosteroid-treatment * inhalative corticosteroid therapy or leukotriene antagonists * alcohol, substance or drug abuse * current smokers * inability to capture extend and consequences of the study

Keywords: allergic asthma, house dust mite allergy bronchial allergen provocation lcpufas
intravaginal artesunate for the treatment of hpv+ high grade cervical intraepithelial neoplasia (cin2/3)

Conditions: Cervical Intraepithelial Neoplasia Grade 2/3; High-risk HPV (Any Strain)

Summary: this phase i research protocol is designed to assess immunogenicity and clinical endpoints in patients with human papillomavirus (hpv) 16 cervical intraepithelial neoplasia (cin)2/3. the protocol tests the use of artesunate in suppository formulation applied intravaginally in patients with cervical dysplasia (cin2/3). the primary endpoint is to determine and evaluate the safety, tolerability, and feasibility of intravaginal administration of artesunate in health women with cin2/3.

phase i open-label dose escalation study of intravaginal artesunate, formulated in suppositories, in adult females with biopsy-confirmed cin2/3. thirty (30) subjects will undergo up to a total of three cycles of intravaginal artesunate. the first cycle will be initiated on day 0, the second at week 4, and the third and final cycle at week 8.

Eligibility criteria:
inclusion criteria: * ≥ 18 years * capable of informed consent * hpv-positive by dna test * histologically confirmed cin 2, cin 3, or cin 2/3 * body weight ≥ 50 kg * immune competent exclusion criteria: * pregnant and nursing women * hiv seropositive * active autoimmune disease * taking immunosuppressive medication * evidence of concurrent adenocarcinoma in situ * concurrent malignancy except for nonmelanoma skin lesions

Keywords: cervical dysplasia hpv treatment preinvasive cervix vaginal suppository cornelia trimble abnormal pap cin